Devices

Device Recall Bivona Uncuffed Neonatal Tracheostomy Tube

  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: 1638874, 1679973, 1713958, 1733048, 1825909, 1878011, 1671976, 1704652, 1708813, 1770355, 1782865, 1793515, 1782708, 1774658, 1825910, 1796685, 1671995, 1692769, 1687755, 1696907, 1713959, 1774659, 1770356, 1804346, 1896192, 1692770, 1704653, 1725263, 1757829, 1766337, 1757828, 1778514, 1774660, and 1814097. Reorder numbers: 60SN025, 60SN030, 60SN035, and 60SN040.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA Nationwide: AZ, CA, CO, CT,DE, FL, GA, HI, IL, IN, KS, KY, LA, SC, TX, OR, NJ, MO, UT, MI, NY, NM, MA, MN, MS, NC, ND, NE, NH, NV, OH, OK, OR, RI, SD, TN, VA, VT, WA, WI, WV including Washinton DC, Australia, Austria, Barbados, Belgium, Brazil, Canada, Chile, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Germany, Gibraltar, Great Britain (UK), Greece, Hong Kong, Ireland, Israel, Italy, Kuwait, Libya, Malaysia, Netherlands, New Zeland, Norway, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, United Arab Emirates, United States, Vatican City State
  • 제품 설명
    Bivona Uncuffed Neonatal Tracheostomy Tube || Sizes 2.5 - 4.0 (With a Straight Neck Flange) || Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up to 29 days. It may be reprocessed up to 5 times for single patient reuse.
  • Manufacturer
    Smiths Medical ASD, Inc.
  • 1 Event

제조사

Smiths Medical ASD, Inc.
  • 제조사 주소
    Smiths Medical ASD, Inc., 5700 W 23rd Ave, Gary IN 46406-2617
  • 제조사 모회사 (2017)
    Smiths Group Plc
  • Source
    USFDA

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Device Recall Bivona Uncuffed Neonatal Tracheostomy Tube
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: 1642703, 1644867, 1651803, 1663881, 1679949, 1687728, 1721269, 1729063, 1725213, 1741726, 1757813, 1848200, 1856117, 1868242, 1900030, 1631488, 1637935, 1644859, 1655821, 1648159, 1663882, 1671974, 1687729, 1692750, 1704578, 1713917, 1725214, 1745583, 1749519, 1749520, 1793487, 1754748, 1774632, 1835034, 1856118, 1809037, 1864898, 1878000, 1891558, 1900031, 1793488, 1913118, 1634468, 1642799, 1651811, 1648156, 1658726, 1675671, 1679950, 1658986, 1692749, 1687731, 1687730, 1704580, 1721271, 1704581, 1749521, 1745584, 1787318, 1778390, 1778389, 1809040, 1809039, 1809038, 1814074, 1817465, 1793489, 1817466, 1835035, 1848201, 1860825, 1864899, 1883533, 1891559, 1904078, 1914909, 1634469, 1642713, 1648151, 1651824, 1658978, 1667767, 1671996, 1683694, 1696912, 1687732, 1704582, 1716552, 1713918, 1725217, 1725216, 1745585, 1741728, 1749523, 1749524, 1757814, 1770345, 1782688, 1782837, 1814076, 1814075, 1829812, 1842425, 1848202, 1860826, 1878001, and 1896181. Reorder numbers: 60N025, 60N030, 60N035 and 60N040.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA Nationwide: AZ, CA, CO, CT,DE, FL, GA, HI, IL, IN, KS, KY, LA, SC, TX, OR, NJ, MO, UT, MI, NY, NM, MA, MN, MS, NC, ND, NE, NH, NV, OH, OK, OR, RI, SD, TN, VA, VT, WA, WI, WV including Washinton DC, Australia, Austria, Barbados, Belgium, Brazil, Canada, Chile, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Germany, Gibraltar, Great Britain (UK), Greece, Hong Kong, Ireland, Israel, Italy, Kuwait, Libya, Malaysia, Netherlands, New Zeland, Norway, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, United Arab Emirates, United States, Vatican City State
  • 제품 설명
    Bivona Uncuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a V-Shaped Neck Flange)
  • Manufacturer
    Smiths Medical ASD, Inc.